I3 INFOTEK INC
Sr. Quality Manufacturing Operations Specialist (Boston)
I3 INFOTEK INC, Boston, Massachusetts, United States, 02298
Job Title:
Quality Development Specialist
Contract (2 Years) Location:
Boston, MA
Managers Note:
Not seeking someone with compliance experience. we need experience with Quality agreements with CMOs/Suppliers.
Job Summary: We are seeking an experienced
Quality Development professional
with hands-on experience in
small molecule manufacturing
to support multiple projects within a fast-paced pharmaceutical environment. The ideal candidate will be a
critical thinker , able to lead investigations, manage quality agreements with external partners, and ensure compliance with GMP regulations across drug substance and drug product manufacturing. Key Responsibilities: Lead and support
Quality Assurance (QA) activities
in a small molecule manufacturing environment. Manage and review
quality agreements
with
CMOs, suppliers, and vendors . Lead
event investigations, root cause analysis (RCA), and CAPA implementation . Ensure
compliance with GMP regulations
across Phase 1-3 drug substance and drug product manufacturing. Review, update, and maintain
batch records, deviations, and CAPAs . Collaborate effectively with
cross-functional teams
and provide clear
written and verbal communication . Support
multiple projects and teams , ensuring timely completion within defined objectives. Utilize
Veeva QMS
or similar quality management systems for documentation and tracking. Required Qualifications: Bachelors or Masters degree in
Pharmacy, Chemistry, Biochemistry, or related field . 2+ years of experience
in Quality Development or Operational QA in small molecule manufacturing. Experience with CMOs, suppliers, or vendors , including managing quality agreements. Strong
critical thinking and problem-solving skills . Working knowledge of
GMP regulations
for drug substance and drug product manufacturing. Experience in
leading investigations, RCA, and CAPA . Proficient in
Veeva QMS
or similar systems. Excellent
communication and collaboration skills . Preferred Qualifications: Experience with
biologics, gene therapy, or medical devices . Project management experience supporting
multiple projects/teams
simultaneously.
Quality Development Specialist
Contract (2 Years) Location:
Boston, MA
Managers Note:
Not seeking someone with compliance experience. we need experience with Quality agreements with CMOs/Suppliers.
Job Summary: We are seeking an experienced
Quality Development professional
with hands-on experience in
small molecule manufacturing
to support multiple projects within a fast-paced pharmaceutical environment. The ideal candidate will be a
critical thinker , able to lead investigations, manage quality agreements with external partners, and ensure compliance with GMP regulations across drug substance and drug product manufacturing. Key Responsibilities: Lead and support
Quality Assurance (QA) activities
in a small molecule manufacturing environment. Manage and review
quality agreements
with
CMOs, suppliers, and vendors . Lead
event investigations, root cause analysis (RCA), and CAPA implementation . Ensure
compliance with GMP regulations
across Phase 1-3 drug substance and drug product manufacturing. Review, update, and maintain
batch records, deviations, and CAPAs . Collaborate effectively with
cross-functional teams
and provide clear
written and verbal communication . Support
multiple projects and teams , ensuring timely completion within defined objectives. Utilize
Veeva QMS
or similar quality management systems for documentation and tracking. Required Qualifications: Bachelors or Masters degree in
Pharmacy, Chemistry, Biochemistry, or related field . 2+ years of experience
in Quality Development or Operational QA in small molecule manufacturing. Experience with CMOs, suppliers, or vendors , including managing quality agreements. Strong
critical thinking and problem-solving skills . Working knowledge of
GMP regulations
for drug substance and drug product manufacturing. Experience in
leading investigations, RCA, and CAPA . Proficient in
Veeva QMS
or similar systems. Excellent
communication and collaboration skills . Preferred Qualifications: Experience with
biologics, gene therapy, or medical devices . Project management experience supporting
multiple projects/teams
simultaneously.